Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research

Malignant Central Nervous System Neoplasm Clinical Trial

Official title:

Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117930
• Other study ID #: MC230707
• Secondary ID: NCI-2023-0479723
• Status: Recruiting
• Start date: February 28, 2024
• Est. completion date: December 13, 2029

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study explores how microorganisms in the gut can affect the growth and progression of brain tumors.

Description:

PRIMARY OBJECTIVES:

I. To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.

II. To use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer.

III. To study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy.

OUTLINE: This is an observational study.

Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 13, 2029
• Est. primary completion date: December 13, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.

Exclusion Criteria:

• Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Malignant Central Nervous System Neoplasm
• Nervous System Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository	Biological samples such as stool, urine, blood, saliva, and/or tissue will be collected for storage in the Tumor-Gut Axis Biorepository. Samples may be collected at any of the following time periods during study participation: before/after steroid therapy, before/after surgical intervention, before/after radiation therapy, and before/after chemotherapy.	Approximately 1 year, or until samples have been collected based on scheduled treatment.